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Antagonist for the Treatment of Moderate-to-Severe Crohn's DiseaseAssistant Professor of Pharmacy, School of Pharmacy, Wingate University, Wingate, NC
Chair and Associate Professor, Pharmaceutical Sciences, School of Pharmacy, Regis University, Denver, CO
Associate Professor of Pharmacy, School of Pharmacy, Wingate University
Reprints: Dr. Smith, School of Pharmacy, Wingate University, Campus Box 3087, Wingate, NC 28174, fax 704/233-8338, susmith{at}wingate.edu
OBJECTIVE: To review certolizumab pegol for the treatment of moderate-to-severe Crohn's disease (CD).
DATA SOURCES: Clinical studies were identified through MEDLINE (1966-October 1, 2009), bibliographies of articles, International Pharmaceutical Abstracts, clinicaltrials.gov, fda.gov, and New Drug Approval documents (www.accessdata.fda.gov). Search terms were CDP 870, certolizumab pegol, Cimzia, Crohn's disease, and inflammatory bowel disease.
STUDY SELECTION AND DATA EXTRACTION: Human studies describing pharmacology, pharmacokinetics, efficacy, and safety of certolizumab pegol were identified. Phase 2 and Phase 3 randomized controlled trials and observational studies were reviewed, with emphasis given to Phase 2 and Phase 3 trials.
DATA SYNTHESIS: Certolizumab pegol is a tumor necrosis factor-alfa
(TNF-
) antagonist, approved for the treatment of moderate-to-severe CD
that is failing conventional therapy. It is an antigen-binding fragment (Fab')
portion of an immunoglobulin G antibody attached to a polyethylene glycol
moiety. In 2 Phase 3 randomized, placebo-controlled trials, certolizumab pegol
was effective in inducing clinical response compared with placebo. Common
adverse effects during clinical trials were upper respiratory tract infection,
urinary tract infection, and arthralgia. Serious infection occurred in 3% of
patients. The 4 published controlled trials for the use of certolizumab pegol
in the treatment of CD share similar limitations with other studies of
TNF- antagonists including high placebo response, natural course of
disease fluctuation, and the use of Crohn's Disease Activity Index to assess
outcomes. However, certolizumab pegol is an effective agent for adults with
moderate-to-severe CD with less than optimal response to conventional therapy.
Long-term efficacy and safety data are unavailable. Certolizumab pegol and
adalimumab, unlike infliximab, can be self-administered.
CONCLUSIONS: With similarity in cost and the lack of head-to-head
comparisons, patient and physician preference may determine choice of
TNF- antagonist.
Key Words: certolizumab pegol, Crohn's disease, inflammatory bowel disease, TNF- antagonist
Published Online, January 5, 2010. www.theannals.com, DOI 10.1345/aph.1M314
THIS ARTICLE IS APPROVED FOR CONTINUING EDUCATION CREDIT
ACPE
UNIVERSAL ACTIVITY NUMBER: 407-000-10-009-H01-P
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